Master Formula of Dried Aluminium Hydroxide Gel ,Magnesium Hydroxide & Activated Methyl Polysiloxane Antacid

PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

1. Master Copy: Manager Quality Assurance

2. Copy No. 1: Production Pharmacist

3. Copy No. 2: Manager Quality Control

PRODUCT NAME: Dried Aluminium Hydroxide Gel ,Magnesium Hydroxide & Activated Methyl Polysiloxane Antacid	BATCH SIZE: 1000 LTRS.
PRODUCT REFERENCE CODE:	UNIT SIZE: 450 ml
GENERIC NAME: N.A.	PACK SIZE: 20 x 450 ml
DOSAGE FORM: SUSPENSION	STRENGTH: N.A.
DEPARTMENT: LIQUID DEPARTMENT	EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each 5 ml contains:

Dried Aluminium Hydroxide Gel I.P. 250 mg

Magnesium Hydroxide I.P. 250 mg

Activated Methyl Polysiloxane I.P 50 mg

Colour: Erythrosine

In a flavoured base

EQUIPMENTS TO BE USED:

SR. NO.	NAME OF EQUIPMENT	ASSEMBLING AS PER SOP NO.	CLEANING AS PER SOP NO.
1	Charging Tank – IV – 1300 Ltrs.
2	Colloid Mill
3	Charging Tank – V – 1300 Ltrs.
4	Storage Tank – III – 1300 Ltrs
5	Linear Bottle Washing Machine
6	Linear Bottle Filling and Sealing Machine
7	Shrink Packing Machine
8	Transfer Pump II

RAW MATERIAL:-

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	AEROSIL	I.P.	1.000		1.000 KGS
2.	ALUMINIUM HYDROXIDE POWDER	I.P.	50.000	10.00	55.000 KGS
3	METHYL PARABEN (PLAIN)	I.P	0.800		0.800 KG
4	ASPARTUM	I.P.	0.500		0.500 KGS
5	BRONOPOL	I.P.	4.000		4.000 KGS
6	CMC SODIUM	I.P.	75.000		75.000 KGS
7	MAGNESIUM HYDROXIDE POWDER	I.P.	50.000	10.00	55.000 KGS
8	MENTHOL	I.P.	0.200		0.200 KGS
9	PROPYLENE GLYCOL	I.P.	4.000		4.000 KGS
10	PROPYL PARABEN (PLAIN)	I.P.	0.200		0.200 KGS
11	SODIUM CITRATE	I.P.	2.000		2.000 KGS
12	SORBITOL SOLUTION	I.P.	240.00		240.00 KGS
13	SPIRIT CHLOROFROM	I.P.	4.500		4.500 LTS
14	SIMETHICONE 30%	U.S.P	33.333	5.00	35.000 KGS
15	ERYTHROSINE COLOUR	F.C.F	75.000		75.000 GMS
16	RASPBERRY FLAVOUR	F.G	2.0000		2.000 KGS
17	XANTHAN GUM	I.P	1.000		1.000 KG

PACKING MATERIAL: –

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	FOR RECORD	TOTAL QUANTITY USED
1.	485 ML AMBER ROUND BTLS.	2222.222		2222.222 NOS
2.	CORRUGATED BOXES WITH 4X 5 JALI	111.111		111.111 NOS
3	ADHESIVE TAPE ROLL BROWN	2.000		2.000 NOS
4	ALOX 450 ML LABELS	2333.333	3.000	2336.333 NOS
5	GUM ACCACIA	1.000		1.000 KGS
6	PILFER PROOFS 25 MM	2222.222		2222.222 NOS

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 450 ml.

Volume variation limit allowed in each filled Bottle is 450 ml to 452 ml.

Make up the final volume of the suspension accurately.

Colloid the completely charged batch using Colloidal Mill L-20 by operating it as per its SOP.

Transfer the suspension from charging tank to storage tank after complete charging of batch.

Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 25⁰ C and Relative Humidity not more than 40.

Yield:

Theoretical Yield is 2222 Bottles.

Expected Practical Yield is 2222 + 2% Bottles.

Packing Details:

Wash the bottles on Linear Bottle Washing Machine and operate it as per its SOP.

Transfer the Suspension from storage tank to Linear Bottle Filling and Sealing Machine for filling and then sealing of the bottles as per its SOP.

Fill 450 ml suspension in 485 ml white glass bottle and use 25 mm PP Cap (rubber washer) to seal the bottle mouth.

Inspect each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.

Label every inspected bottle by using the Automatic Bottle Labelling Machine as per its SOP

Pack 20 filled and sealed bottle in each corrugated box.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Soak 4.00 kgs of C.M.C Sodium and 1.00 kg of Xanthan Gum in 30 liters of Purified water in Stainless Steel Containers and keep it for 6 hours.

Charge 15 kgs of Sorbitol to charging tank L-09

Addition of Ingredients into the Charging Tank while stirring continuously:

Dissolve 2.0 kgs of Sodium Citrate in 5 Liters of Purified water and add to the bulk batch.

Dissolve 0.500 kgs of Aspartum 2.0 Ltrs of Purified water and add to the bulk batch.

Slowly transfer 55.00kgs of Aluminium Hydroxide Powder to the bulk batch.

Add 200 Ltrs of Purified Water to the bulk batch.

Slowly transfer 55.00 kgs of Magnesium Hydroxide Powder to the bulk batch.

Add 1.6 kgs of Aerosil to the bulk batch.

Dissolve 0.500 kgs of Bronopol in 2 Ltrs of Purified water and add to the bulk batch.

Slowly transfer 35.00 kgs of Simethicone to the bulk batch.

Dissolve 0.75 kgs of Erythrosine color in 5 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.800 kg of methyl paraben (plain) and 0.200 kg of Propyl paraben (plain) in 4.0kgs.of hot P.G and add to the bulk batch.

Mix the whole batch for 1 hour and then colloid the batch.

Colloid the batch through Colloid Mill by operating it as per its SOP and transfer it to the Charging Tank.

Dissolve 0.200 kgs of Menthol in 4.5 liters of Spirit Chloroform and add to the bulk batch

Add 2.0 liters of Raspberry flavor to the bulk batch.

Make up the volume with Purified water to 1600 Ltrs and mix until homogeneous.

Leave the Suspension to settle for overnight or for minimum 8 hours.

Again check the volume and make up with Purified water to 1000 Liters and mix until homogeneous.

Check the self pH of Solution to be in between 8.0 – 9.0

Send the sample to Quality Control Department for bulk testing.

Transfer it to the Storage Tank .

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Final volume should be made as per Standard Operating Procedure using correct dipstick in the Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Limit for Volume Variation: Volume claimed on the label + 2ml

Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.

Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.

The labels and cartons should be checked thoroughly for proper batch coding.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.